Stark and Anti-Kickback

Stark, Stark And More Stark – Stark Is Here To Stay

Stark And Anti-Kickback Experience

Adrienne Dresevic, Esq.  , one of the founding partners of The Health Law Partners, P.C., leads the firm’s Stark, Anti-Kickback and Fraud and Abuse practice group. Ms. Dresevic has analyzed hundreds of arrangements and relationships and regularly counsels and advises clients on issues related to Stark and fraud and abuse. She is a nationally recognized author, with numerous publications  to legal and professional organizations regarding Stark, Anti-Kickback, and fraud and abuse. Some of these publications include the following:

"OIG Again Views Complimentary Transportation Services Favorably," by Adrienne Dresevic, Esq. and Carey F. Kalmowitz, Esq., AHRA Link, April 2011.

Group Practice Integration in Light of PPACA and Stark,” by Adrienne Dresevic, Esq. and Carey F. Kalmowitz, Esq., Michigan Medical Law Report Winter 2011.

Regulatory Review: CMS Issues Final Rule Regarding Stark’s IOASE Disclosure Requirement,” Adrienne Dresevic, Esq.  and Carey F. Kalmowitz, Esq., AHRA Link, December 2010.

Physicians Must Manage New Stark Law Risks Under the Health Care Reform Act,” by Adrienne Dresevic, Esq. and Carey F. Kalmowitz, Esq., Michigan Medical Law Report Fall 2010.

"Regulatory Review: Physician Self-Referral Updates," by Adrienne Dresevic, Esq. and Carey Kalmowitz, Esq., AHRA Link, May 2010.

"The 2009 Medicare Physician Fee Schedule: The Anti-Markup Rule and IDTF Developments Impacting Diagnostic Testing Services," co-authored: Adrienne Dresevic, Esq., The Health Lawyer, The ABA Health Law Section, Vol. 21, No. 3, February 2009

"CMS Finalizes Major Stark Changes - New Physician Self-Referral Rules in the 2009 IPPS Final Rulemaking Will Require Restructuring of Many Common Healthcare Arrangements," co-authored: Adrienne Dresevic, Esq., The Health Lawyer, The ABA Health Law Section, October 2008

"2008 Medicare Physician Fee Schedule: Despite Non-Finalization of Stark Proposals, Final Rule Contains Major Implications for Diagnostic Testing Arrangements," co-authored: Adrienne Dresevic, Esq., The Health Lawyer, The ABA Health Law Section, February 2008

"Stark II Phase III - The Full Picture," co-authored: Adrienne Dresevic, Esq., Special Edition: The Health Lawyer, The ABA Health Law Section, September 2007

"Stark and Anti-Kickback Protection for E-Prescribing and Electronic Health Records," co-authored: Adrienne Dresevic, Esq., The Health Lawyer, The ABA Health Law Section, Vol. 18, No. 2, December 2005

"Stark II - Phase II - The Final Voyage," co-authored: Adrienne Dresevic, Esq., Special Edition: The Health Lawyer, The ABA Health Law Section, April 2004

Ms. Dresevic also frequently speaks to professional organizations and to physician groups regarding Stark and fraud and abuse.

Carey Kalmowitz, Esq.  also has extensive experience advising healthcare providers and organizations with regard to Stark and fraud and abuse. In his 15 years of practice, Mr. Kalmowitz has been engaged to structure, as well as restructure, an extensive number of transactions, involving physicians, hospitals and other providers and suppliers, across the spectrum of healthcare disciplines. In particular, providers have looked to Mr. Kalmowitz to develop frameworks that navigate Stark and Anti-Kickback Statute challenges, while simultaneously permitting the parties to realize their economic objectives. As the complexity of healthcare regulation has increased, clients across the country have sought Mr. Kalmowtiz's healthcare and business acumen to preserve the economic vitality of transactions, while ensuring that the transactions remain Stark and Anti-Kickback Statute compliant.

Stark Overview

Generally speaking, the federal Stark law prohibits physicians from referring Medicare beneficiaries to an entity in which they (or an immediate family member) have a financial relationship for designated health services (“DHS”), unless an exception applies.

Stark DHS

There are several categories of DHS. Some of these categories are defined by reference to CPT and HCPCS codes. These include:

  • Clinical laboratory services
  • Physical therapy services
  • Occupational therapy and speech pathology services
  • Radiology and certain other imaging services
  • Radiation therapy and supplies

The list of codes is updated on an annual basis in the physician fee schedule. This list is also maintained on the CMS website.

The remaining DHS categories are based upon regulatory descriptions, and not codes. These categories include:

  • Durable Medical Equipment (“DME”) and supplies
  • Parenteral and enteral nutrients, equipment and supplies
  • Prosthetics, orthotics and prosthetic devices and supplies
  • Home health services
  • Outpatient prescription drugs
  • Inpatient/outpatient hospital services

Common Relationships Impacted By Stark

Many common relationships can trigger the need for a Stark analysis. Examples of common healthcare relationships that can trigger Stark include, but are not limited to, the following:

  1. Physician employment and independent contractor agreements
  2. Equipment and space lease agreements
  3. Medical director agreements
  4. Hospital/physician recruitment agreements
  5. Arrangements between physicians and other DHS providers (e.g., DME suppliers and home health agencies)

Stark’s Applicability Within The Group Practice

Many do not understand that Stark applies even within a physician group practice. Stark applies to referrals of DHS within a physician group practice. For example, if a practice provides physical therapy, X-rays, or ultrasounds within its practice, Stark will be implicated and the relationship between the physicians and the practice must be analyzed to ensure compliance with a Stark exception.

Stark Penalties

Penalties for violating Stark can be severe. Stark penalties include denial of payment, refund of payment, imposition of a $15,000 per service civil monetary penalty and imposition of a $100,000 civil monetary penalty for each arrangement considered to be a circumvention scheme. Healthcare providers also should bear in mind that Stark violations can be raised in the context of civil false claims suits brought by whistleblowers.

Stark Helpful Links

The following is a link to the CMS website "Physician Self-Referral Quick Reference Guide." This page contains links to the Stark statute and Federal Register documents. The website is located at http://www.cms.hhs.gov/physicianselfreferral/

The following is a link to an overview of Stark Law including guidance regarding physician investments, referrals, and penalties. The website is located at http://starklaw.org/

Stark Questions?

Stark inquiries can be directed to Adrienne Dresevic, Esq. or to Carey Kalmowitz, Esq.  at (248) 996-8510 or (212) 734-0128.